Method of using an optical female urethroscope

ABSTRACT

A female urethroscope includes a detachable, disposable semi-flexible sheath for insertion into a female&#39;s urethra. The sheath is provided with plurality of channels. One of the channels may receive an endoscope for optical examination of an operative site within the urethra. The remaining channels may be used for suction, drainage, or irrigation of the operative site. The disposable sheath provides a significant improvement in the efficiency and sterility of internal surgical procedures, and is specifically sized and configured for comfortable use in the female&#39;s urethra. Further, the urethroscope includes an inflation medium for applying pressure to, and relieving such pressure from, the interior walls of the female&#39;s urethra. In a particular embodiment for use as a female urethroscope, the urethroscope has a tube-shaped member having an insertion portion dimensioned for comfortable insertion into a female patient&#39;s urethra. The overall diameter of the distal end of the instrument preferably is less than about 7 mm, and most preferably is less than about 4 mm. The length of an insertion portion preferably is less than about 150 mm.

This application is a continuation-in-part of patent application Ser.No. 08/400,919, which was filed on Mar. 8, 1995, now U.S. Pat. No.5,536,234 which is a continuation of patent application Ser. No.08/108,980, which was filed on Aug. 18, 1993, now abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to optical medical devices for use insurgical procedures. More particularly, the present invention relates toan optical surgical device, configured for use as a female urethroscope,that may be used to remove tissue, blood, or other liquid andparticulate matter.

2. Description of Related Art

Certain gynecological procedures require a physician to examine,diagnose and often remove or extract tissue, blood, or other matter froman operative site within the patient. For example, in one relativelycommon procedure, the physician must accurately locate uterine tissue tobe removed, scraped, and/or aspirated. In other procedures, thephysician may want to examine the patient's fallopian tubes or otherinternal areas to diagnose or biopsy other medical problems ordifficulties, or simply to insure that the desired results have beenachieved.

Different forms of endoscopes have been used to access and examine suchoperative sites within the patient's body. Typically, such endoscopescomprise bundles of long optic fibers which extend into the body cavitybeing examined. Some conventional endoscopes include multiple channels,or lumens, extending alongside or concentric with the optic fiberbundles. These channels may be used to introduce a flushing fluid intothe operative site or to provide a conduit for other instruments toreach the desired area.

Conventional disposable endoscopes, however, generally do not allow acontinuous flow of irrigation fluid into the operative site to cleanboth the operative site as well as the endoscope, while simultaneouslyremoving the fluid and other particulate matter from the area. Instead,in some conventional devices, a single lumen is designated for bothsuction and irrigation functions. As a result, suction and irrigationcannot occur simultaneously. The suction and irrigation functions mustoperate in an alternating fashion. In other devices in which separatechannels are provided for inlet and outlet fluids, the correspondingopenings typically operate so that a stream of fluid that is inletthrough one port is later outlet through another port in an alternatingfashion. Such an endoscopic device still does not operate, however, as acontinuous flow system in which irrigation and suction can occursimultaneously and continuously.

Another drawback of some conventional endoscopic tools is that they areoften uncomfortably large or wide in diameter. For example, manytraditional endoscopes use glass rods and lenses to deliver light anddisplay images. However, due to the materials and methods used, suchrelatively large devices have been known to cause significant discomfortduring insertion and manipulation after being inserted. Often, due tothe physical size limitations of the endoscope device, the physician mayperform the surgery without visually examining the operative area.

One device that includes some of the drawbacks described above is shownin FIGS. 1-3 of U.S. Pat. No. 4,998,527 to Meyer (issued Mar. 12, 1991).Meyer discloses a complicated network of tubes combined in a metalsleeve. Each tube is designated for a specific function. For example,one of the tubes carries a resecting mechanism which breaks down largepieces of tissue into smaller pieces to be suctioned into another tube.As a consequence, however, the metal outer sleeve must be sufficientlylarge to retain the network of tubes, channels, etc.

Furthermore, conventional endoscopes are typically designed with rigidouter sleeves or sheaths made of a rigid plastic or metal material, suchas that described above in the Meyer device. Such construction, however,is often difficult to manipulate within a patient's body, and generallyrequires extensive cleaning and sterilization after each use. Althoughsome endoscopes incorporate both rigid and flexible materials forgreater maneuverability during insertion and examination, suchconstruction often requires substantial cleaning and sterilization toremove all contaminants trapped within the various crevices and openingsof the different materials.

Moreover, it is particularly problematic to properly clean and sterilizetubes and conduits that form the lumens contained within conventionalendoscopes. Because of the universal desire to maximize the patient'scomfort during the examination, the lumens are typically designed to beas small as possible. Nevertheless, such small openings tend toexacerbate the difficulty in properly cleaning and sterilizing theendoscope.

Finally, conventional endoscopes do not conform comfortably to thefemale anatomy. The dimensions of the female urethra require that anendoscope be specially sized in order to reduce the patient's discomfortas much as is possible. Conventional endoscopes have not been sodesigned. Further, conventional endoscopes have failed to provide acomfortable means by which to dilate the urethra, let alone combinedsuch means with lumens for passage of an endoscope and/or forirrigation, drainage, and biopsy.

Therefore, a need exists for an endoscope, sized and configured for thefemale urethra, that has means for dilating the urethra and at least onelumen.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide animproved optical endoscopic device for use as a female urethroscope, aswell as a method of making and using the same, obviating for practicalpurposes the above-mentioned limitations and disadvantages of therelated art.

These and other objects and advantages are accomplished, according to anembodiment of the present invention, by an optical surgical devicehaving an outer sheath constructed with multiple channels, or lumens,extending through the length of the sheath. The sheath, according to theillustrated embodiments, is disposable. Preferably, for each procedure,a new, pre-sterilized sheath is used. This minimizes the risk ofcontamination and decreases the amount of time directed to the propercleaning and sterilization of the sheath and multiple channel structure.Thus, the disposable feature significantly reduces the possibility ofcontamination and infection due to inadequate cleaning or sterilizationof the sheath.

The sheath is preferably made of a semi-flexible plastic, vinyl or othermaterial appropriate for the particular application. For example, thesheath may be formed of a rigid plastic with a curved scraping end foruse as a curette in urinary tract or other procedures in which tissue orfluid is removed around the operative site.

In the illustrated embodiment of the sheath, three channels are showndisposed adjacent each other. An endoscope is provided in one of thechannels of the sheath to enable the physician to optically examine theoperative site within the patient. The endoscope is comprised of bundlesof optic fibers extending through the entire length of the correspondingchannels in the sheath. The endoscope is first inserted into one of thechannel openings at the proximal end of the sheath, and then fed throughthe channel until it reaches the end of the channel at the distal tip ofthe sheath. The endoscope can be quickly disengaged from the sheath bysimply sliding it out of its designated channel.

The remaining channels may be occupied by suction and/or irrigationsources, or other medical devices. Preferably, the suction channel isthe largest channel so that fluid or tissue scraped or removed from theoperative site does not clog or block the pathway. A source ofirrigation is supplied to flush the operative site, if necessary, aswell as to clean the viewing area at the distal tip of the endoscope.The irrigation solution is simply supplied through the designatedirrigation channel while the patient's bodily tissue and fluid, as wellas the irrigation solution, are drained through the suction channel.

In a particular embodiment for use as a female urethroscope, theurethroscope has a tube-shaped member having an insertion portiondimensioned for comfortable insertion into a female patient's urethra.The overall diameter of the distal end of the tube-shaped memberpreferably is less than about 7 mm, and most preferably is less thanabout 4 mm. The length of the insertion portion preferably is less thanabout 150 mm. The female urethroscope preferably has an inflation mediumdisposed near the distal end of the tube-shaped member and at least twochannels (or lumens) formed within the tube-shaped member. The channelsmay include any of an endoscope channel, an irrigation channel, adrainage channel, and/or an insufflation channel for inflating anddeflating the inflation medium. The insertion portion may have a curvedshape for ease of viewing access within the patient's urethra andbladder. Optionally, the tip of the insertion portion may have a scraperor other tool.

Thus, the above-described arrangement of the present invention allowsthe physician to visually examine, for example, a patient's bladderbefore, during, and after a urinary tract procedure. The physician mayirrigate or insufflate the operative site, accurately locate targettissue, and then scrape and/or remove by suction the tissue, withsubstantially reduced discomfort to the patient.

The details of the preferred embodiment of the present invention are setforth in the accompanying drawings and the description below. Once thedetails of the invention are known, numerous additional innovations andchanges will become obvious to one skilled in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an optical surgical device according toone embodiment of the present invention.

FIG. 2 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 2--2 shown in FIG. 1.

FIG. 3 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 3--3 shown in FIG. 1.

FIG. 4 is a side view of a portion of the optical surgical device of theembodiment in FIG. 1.

FIG. 5 is a perspective view of one aspect of the optical surgicaldevice.

FIG. 6 is a cross sectional view of a portion of the optical surgicaldevice along the lines 5--5 shown in FIG. 1.

FIG. 7 is a side view of a portion of one aspect of an optical surgicaldevice.

FIG. 8 is a side view of a portion of another aspect of an opticalsurgical device.

FIG. 9 is a perspective view of an optical surgical device according toanother embodiment of the present invention.

FIG. 10 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 10--10 shown in FIG. 9.

FIG. 11 is a cross-sectional view of a portion of the optical surgicaldevice along the lines 11--11 shown in FIG. 9.

FIG. 12 is a side view of a portion of the optical surgical device ofthe embodiment shown in FIG. 9.

FIG. 13 is a perspective view of an alternative embodiment of aurethroscope in accordance with the present invention, the urethroscopebeing dimensioned and configured for the female anatomy.

FIG. 14 is a perspective view of the embodiment illustrated in FIG. 13,showing an optical viewing device protruding from both the proximate anddistal ends of the urethroscope.

FIG. 15A is a side view of an alternative embodiment of a urethroscopein accordance with the present invention, the urethroscope beingdimensioned and configured for the female anatomy, showing an inflationmedium in a deflated state.

FIG. 15B is a cross-sectional view of the distal end of the urethroscopeillustrated in FIG. 15A, with the inflation medium in the deflatedstate.

FIG. 16A is a side view of the embodiment illustrated in FIG. 15,showing the inflation medium in an inflated state.

FIG. 16B is a cross-sectional view of the distal end of the urethroscopeillustrated in FIG. 16A, with the inflation medium in the inflatedstate.

FIG. 17A is a side view of a two-lumen female urethroscope.

FIG. 17B is an enlarged side view of the distal tip of the two-lumenfemale urethroscope of FIG. 17A.

FIG. 17C is a cross-sectional side view of the two-lumen femaleurethroscope of FIG. 17A.

FIG. 17C is an enlarged cross-section side view of the distal tip of thetwo-lumen female urethroscope of FIG. 17A.

Like reference numbers and designations in the various drawings indicatelike elements.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description is of the best presently contemplatedmode of carrying out the invention. This description is not to be takenin a limiting sense, but is made merely for the purpose of illustratingthe general principles of embodiments of the invention. The scope of theinvention is best defined by the appended claims.

FIG. 1 is a perspective view of an optical surgical device 10 accordingto an embodiment of the present invention. As discussed in more detailbelow, embodiments of the present invention are suitable for use in avariety of intrauterine or other internal examination procedures, suchas aspiration biopsy, artificial insemination techniques, amniocentesis,chorionic villa sampling, and urethra, urinary bladder and bowelendoscopy, for example. Embodiments of the present invention providesignificant advantages in that the physician may more clearly examinethe body cavity or operative area during the intrauterine or internalsurgical procedure with minimal obstruction. In addition, otherembodiments of the present invention allow for video documentation ofthe procedure if desired.

Thus, the physician may accurately locate the tissue to be removed,irrigate or insufflate the operative site, and scrape and/or use suctionto remove the desired tissue, while concurrently viewing each step ofthe procedure. Consequently, the occurrence of inadvertent accidentssuch as perforation of the operative site or body cavity, e.g. thepatient's uterus, is significantly reduced.

While various embodiments of the present invention may also be suitablefor other surgical and diagnostic procedures, as described in moredetail below, the described embodiments are preferably directed for usewithin any areas of a patient's body for which visual examination isparticularly helpful. For example, during a biopsy procedure of tissueor fluid within a patient's urethra or bladder, optical diagnosis andexamination of the surgical procedure may be especially useful. It willbe recognized that further embodiments of the present invention may besuitable for various other biopsy procedures, such as (but not limitedto) biopsies of the breast, lung, kidney, and almost any other internalorgan or cavity in which optical probing capabilities are necessary toreach and ultimately examine the desired operative site.

As illustrated in FIG. 1, the optical surgical device 10 comprises,generally, an elongated sheath 12 containing multiple channels 14, 16,and 18. Each channel is designated for a specific function. For example,channel 14 may be designated for suction or drainage purposes.Preferably, the center channel 16 is designated for insertion of anendoscope (not shown). The endoscope may be inserted in the channel 16at the proximal end 24 of the sheath 12, and pushed through to thedistal end 20 of the sheath 12. The endoscope extends through the lengthof the sheath 12. The endoscope is preferably formed of a bundle ofoptical fibers which carry images from the distal end of the device tothe proximal end. In addition, light delivery fibers may be provided forilluminating the examined area. Depending upon the configuration of theendoscope, a light source may be coupled to the endoscope fibers toilluminate the operative site.

The third channel 18 is provided as an irrigation line through which anirrigating or flushing fluid may flow to irrigate the operative siteduring the surgical procedure, while simultaneously cleaning theendoscope. In other embodiments, the irrigation channel 18 may be used,for example, as a gas inflow channel through which a gas, such as carbondioxide (CO₂), may be directed to insufflate the operative site.

It will be recognized that the suction and irrigation functions may beperformed using the designated channels in the sheath 12 throughseparate tubing which may be connected to the channels provided in thesheath 12. For example, individual suction and irrigation tubes, orlines, may be attached to the external sources of the suction andirrigation. Thus, the preformed, predefined channels themselves maycomprise the pathways for suction and irrigation.

As illustrated in FIG. 1, the proximal end 24 (on the left side of thefigure) of the optical surgical device 10 is provided with two ports 22and 23. As shown in FIG. 2, the suction/irrigation port 22 includes theproximal openings for the suction and irrigation channels 14 and 18,respectively. In FIG. 3, the cross-section of the proximal endoscopeport 23 shows the endoscope channel 16 and viewing area at approximatelythe center of the port 23. Preferably, the suction/irrigation port 22 isoffset from the proximal endoscope port 23 for reasons discussed below.

As shown in FIGS. 1 and 4, an eyepiece port 32 is coupled to the openend of the proximal endoscope port 23. Preferably, the eyepiece port 32extends along the same line as the sheath 12 and endoscope channel 16.The in-line construction of the eyepiece port 32 facilitates easieraccess to the viewing angle as the sheath 12 is rotated or manipulatedwithin the operative site. Otherwise, if the eyepiece port is offsetfrom the body of the sheath and endoscope, as in some conventionalendoscopes, the physician must physically adjust his or her viewingposition to accommodate the changing position of the rotating eyepieceport. Instead, in preferred embodiments of the present invention, thephysician does not have to sacrifice balance and control of the opticaldevice while adjusting the position of the device during the examinationprocedure.

The eyepiece port 32 is attached over the endoscope port 23 at theproximal end 24 of the sheath 12. The funnel-shaped eyepiece port 32receives a conical eyepiece 33 (FIG. 5). Preferably, a metal or rigidcovering surrounds the optical fibers of the endoscope for coupling tothe distal end of the eyepiece 33. Various eyepieces 33 may be used fordifferent examination procedures. For example, depending upon thedesired degree of optical examination, the eyepiece may requiremagnifying or focusing capabilities. A preferred eyepiece embodiment, asillustrated in FIG. 5, includes a focusing ring 36 located at theproximal end of the eyepiece 33 for manual adjustment by the user. Itwill be recognized, however, that various other manual or automaticfocusing and magnifying techniques may be implemented to enable a clear,focused view of the operative site through the eyepiece and endoscopeassembly.

The distal end of the eyepiece 33 is provided with a conical-shapedlocking mechanism 38 for attachment to the eyepiece port 32, shown inFIG. 4. The locking mechanism 38 is inserted into the funnel shapedopening of the eyepiece port 32 for a secure fit. Preferably, a screw-ontype locking mechanism is used to screw the eyepiece 33 to the eyepieceport 32. However, other friction-fit devices or methods may also be usedto ensure a tight seal between the eyepiece and the sheath. In addition,a gasket 34 may be used to further prevent leakage of irrigatingsolution and other fluid, or to prevent the insufflating gas fromescaping, around the periphery of the eyepiece port connection.Alternatively, port 32 can be integrally formed on the proximal end 24of the sheath 12.

A preferred eyepiece has been developed by Ideation Engineering in whichglass lenses and prisms are used to magnify and focus images seenthrough the endoscope. A focusing ring is provided on the eyepiece. Theconical-shaped eyepiece includes a cone-shaped locking mechanism whichcan be twist-fit into the eyepiece port. The eyepiece 33 may beconnected to a medical video camera or may be used for direct viewing.If a video camera is used, the output may be coupled to a head-mounteddisplay unit.

As described above, the suction/irrigation port 22 is preferably offsetfrom the proximal endoscope port 23 to prevent obstruction of orinterference with the viewing area around the endoscope eyepiece, aswell as to separate the sources of fluid or gas from the eyepiece.Depending upon the rigidity of the material which forms the sheath 12and the ports 22 and 23, an angle support brace 26 may be provided inthe angular separation between the suction/irrigation port 22 and theproximal endoscope port 23. For example, if the sheath and therespective channels and ports are made of a flexible material, the anglesupport brace 26 may be used to keep the tubing, cables, etc. of thesuction and irrigation supply lines from draping over the endoscopeeyepiece. Thus, the support brace 26 functions to maintain and brace theseparation between the two ports to avoid obstruction of the endoscopeviewing area by the suction/irrigation supply lines.

FIG. 2 shows the suction/irrigation port 22 divided into two channelopenings 14 and 18. The diameters of the suction and irrigation channelsmay vary depending upon the desired use for the optical surgicalinstrument. For example, the cross-section of the suction (or drainage)channel 14 may be larger than that of the irrigation channel 18. Thus,if the tissue to be removed around the operative site is primarilycomprised of the endometrial lining of the uterus, it may be desirableto have a large suction channel 14 relative to the irrigation channel 18so that the tissue can be scraped and removed from the operative areawithout clogging the channel. Simultaneously, the operative site may beirrigated with a thin, continuous stream of water or other irrigatingsolution.

For other procedures such as, for example, aspiration biopsy orfallopian tube insemination, the suction channel 14 may be smallrelative to the irrigation channel 18 to limit or control the amount oftissue and/or fluid injected into or removed from the operative site.For example, in an insemination procedure, it may be desirable to employa sheath having a large irrigation channel for use as a fluid injectionchannel. A "suction" function then may be completely unnecessary.

As shown in FIG. 2, the proximal openings of the suction and irrigationchannels 14 and 18, respectively, are circular or oval in shape. It willbe recognized that the particular configuration, shape, and size of eachof the channels within the sheath 12 may vary according to theparticular application. For example, the shapes of the suction channel14 and the irrigation channel 18 will preferably be circular ifstandard-gauge tubing is to be inserted through the preformed channelswithin the sheath 12, rather than using the channels as direct conduitsbetween the suction/irrigation port 22 and the distal tip 28 of thesheath. The sheath, as well as the channels contained therein, may thushave a variety of shapes and lengths for use in different surgicalprocedures.

In any internal examination procedure, however, the sheath preferablycontains a minimum number of channels necessary to perform the medicalprocedure, yet ensure patient comfort during insertion and manipulationof the surgical device. Thus, to meet the needs for patient comfort andcontrollability of the device during the surgical procedure, the sheathstructure 12 of the described embodiments is tapered, as illustrated inFIG. 1. The diameter of the sheath 12 is larger at the proximal end 24as compared to the distal end 20 of the sheath 12. Because the distalhalf 20 of the sheath 12 is inserted into the patient during theoperative procedure, the slim configuration of the distal end 20 of thesheath 12 minimizes patient discomfort during insertion and enhancesmaneuverability during the examination procedure. Similarly, the widerproximal end of the sheath 12 provides for easy handling and control ofthe sheath 12 by the physician.

In another aspect of the illustrated embodiment, the sheath material ispreferably semi-flexible to allow the physician to maneuver the sheathinto the desired location and position, yet sufficiently rigid forproper control of the endoscope during the examination. Thus, thematerials used to form the sheath 12 may vary depending upon theprocedure to be performed. Furthermore, the walls of the proximal half24 of the sheath may be constructed to be thicker, and therefore morerigid, than those of the distal end 20 of the sheath. In such aconfiguration, although the diameters of the channels within the sheath12 may be uniform through the entire length of the sheath, the externalstructure of the sheath may nevertheless be tapered to enhanceflexibility and manipulability of the sheath during an examination.

FIG. 6 shows a cross-section of the distal half 20 of the sheath 12. Inthe illustrated embodiment, the suction, endoscope, and irrigationchannels are arranged in a side-by-side fashion. The suction channel 14is shown larger than the endoscope and irrigation channels 16 and 18,respectively. As described above, the suction channel 14 is preferablysufficiently large to facilitate the removal of tissue and othersubstances around the operative site. The center channel 16 accommodatesthe endoscope (not shown). Preferably, the width of the endoscopechannel 16 is approximately 1 mm. The remaining lumen 18 provides a pathfor irrigation or insulation of the operative site. This channel is alsopreferably approximately 1 mm in size.

The overall diameter of the distal portion 20 of the sheath preferablyis less than about 7 mm, and most preferably is less than about 4 mm. Itwill be recognized that the diameter of the distal portion 20 of thesheath 12 is significantly smaller than many conventional opticalsurgical tools to provide increased patient comfort, and adjustabilityand control of the surgical device during the operative procedure. Theselected size, however, will vary depending on the number of channelsnecessary for the particular surgical procedure.

In yet another aspect of the illustrated embodiments of the presentinvention, the shape of the distal tip 28 of the sheath 12 may varydepending upon the particular application of the optical surgical device10. The particular tip structure may be selected to allow the physicianto directly view and precisely locate the desired operative site, andthen scrape and/or suction the target tissue or fluid. Examples ofcurved and blunt distal tips are shown in FIGS. 1, 7, and 8. A curvedtip 46 (FIGS. 1 and 7), for example, provides both physical and visualaccess to nearly any area of an operative site as the sheath 12 isrotated or manipulated manually by the physician. The curved tip 46 maybe useful in procedures such as aspiration biopsies. The hook-likeconfiguration facilitates the dislodging of the desired tissue from theoperative site (e.g., the lining of the bladder), and directs thedislodged tissue into the suction channel 14. Preferably, the curved tip46 is positioned sufficiently beyond the distal opening of the endoscopechannel 16 to avoid obstruction of the endoscope.

In another preferred embodiment of the invention, the sheath 12 may beprovided with a blunt tip 44 (FIG. 8) which may be useful in a number ofprocedures. The blunt tip 44 allows the physician to clearly view thedesired tissue, place the tip adjacent the tissue, and remove the tissueby scraping or suction.

As illustrated in FIGS. 1, 7 and 8, the endoscope channel 16 is disposedbetween the suction and irrigation channels 14 and 18, respectively.Such a configuration provides for continuous cleansing of the tip of theendoscope during the surgical procedure. The continuous flow ofirrigating fluid provides an unobstructed view of the operative sitethrough the endoscope. In addition, the irrigating fluid may be suppliedor delivered only on demand. For example, if a continuous flow ofirrigating fluid is unnecessary, if the view through the endoscopebecomes clouded by blood or other tissue, the tip can instantly becleaned by applying suction and irrigation simultaneously. Thus, as theirrigating fluid flows into the operative site, across the tip of theendoscope, the fluid and any tissue may be quickly flushed out andextracted through the suction channel 14.

In another preferred embodiment of the present invention, the opticalsurgical device may be used for examining a patient's urethra andbladder. An embodiment of an optical urethroscope 50 is illustrated inFIG. 9. When used to examine female patients, the distal end 52 of theurethroscope 50 is inserted into the patient's urethra, similar to theoperation of the optical surgical device 10. Thus, preferably, thedistal end 52 of the urethroscope 50 is slimmer, i.e., has a smallerdiameter, than the proximal end 54.

The urethroscope 50 may be provided with multiple channels, or lumens56, 58 and 60 formed within an outer sheath 62. Preferably, an endoscope(not shown) is inserted into the center channel 58 of the sheath 62. Adrainage channel 56 is designated for outflow of fluids from theurethra, while an irrigation channel 60 is provided for inflow ofirrigating fluid.

The urethroscope 50 may also include an eyepiece coupled to an eyepieceport 64 at the proximal end 54 of the sheath 62, as shown in FIG. 9. Agasket may be inserted between the eyepiece port 64, at proximal end ofthe endoscope channel 58 of the sheath 62, and the eyepiece to preventleakage of urine or other fluid around the eyepiece during use. FIG. 9shows the eyepiece port 64 extending generally in-line with theelongated body of the sheath 62. As described earlier, such aconfiguration provides direct viewing capability of the operative sitewithout requiring the physician or video apparatus to be shifted ormoved whenever the sheath and eyepiece arrangement are rotated oradjusted.

Like the embodiment of the optical surgical device 10 illustrated inFIG. 1, the drainage channel 56 and irrigation channel 60 form thedrainage/irrigation port 66 which is offset from the proximal endoscopeport 54. The size and structure of the drainage and irrigation channels56 and 60 may be substantially configured to fit standard drainage andirrigation connectors and tubing.

In another aspect of the urethroscope embodiment of the presentinvention, the urethroscope may be equipped with an inflation medium,such as a balloon, to dilate the urethra, if necessary. Rather thanusing the conventional method of inserting graduated sizes of metal rodsto dilate the urethra, the urethroscope may be used for dilation as wellas examination. As shown in FIGS. 9-11, a balloon 68 may be providedaround part of the distal end 52 of the sheath 62. The balloonpreferably is formed of a plastic or rubber material wrapped around theouter circumference of the distal section 52 of the sheath to beinserted into the patient.

The balloon 68 is coupled to a balloon inflation channel 71. The ballooninflation channel 71 extends longitudinally adjacent the irrigationchannel 60, as indicated in FIG. 11. An external source of an inflatingmedium (not shown) may be coupled to the balloon inflation channel 71 atthe balloon inflation port 70 shown in FIG. 9. In the illustratedembodiment, the balloon inflation port 70 is angled away from theballoon inflation channel 71, and therefore the body of the sheath 62,to facilitate easy hook-up to the inflation medium and minimizeobstruction of the viewing area. Preferably, the balloon inflation port70 comprises a Luer lock system in which water, air or other inflatinggas that has been injected into the balloon through the ballooninflation port 70 cannot escape. The Luer lock essentially acts as aone-way gas inlet.

Accordingly, during an examination procedure of the urethra, forexample, after the physician has inserted the urethroscope 50 into thepatient's urethra, the physician may quickly, yet controllably dilatethe urethra by inflating the balloon 68. As the balloon expands, theurethra is slowly forced to expand, or dilate. FIG. 10 illustrates across-section of the inflated balloon 68 surrounding the sheath 62.Preferably, the balloon 68 extends from outside of the patient to beyondthe length of the urethra so that the entire length of the patient'surethra may be dilated with minimal trauma and discomfort.

The size and construction of the described embodiment of theurethroscope may be varied to accommodate different patients andprocedures while minimizing discomfort. For example, the distal half 52of the sheath 50 (which will be inserted into a patient) preferably iscurved, as shown in FIG. 9. The slight curvature provides sufficientflexibility and access both physically and visually to the various areasof the operative site being examined. In addition, the distal tip 73 ofthe illustrated embodiment of the urethroscope may be rounded (FIG. 12)to facilitate more comfortable insertion. Preferably, the endoscope isinserted into the central channel 58 of the sheath 62 such that theendoscope viewing area protrudes from the rounded tip 73 of the sheath.As a result, the endoscope field of view is increased.

As illustrated in FIGS. 9 and 12, the drainage opening 72 at the distalend of the drainage channel 56 may be skewed off to the side of the tip73 of the sheath 62. Since drainage is a passive function, in contrastto active suction, the physician typically does not need to directlyview the drainage of fluid through the drainage opening 72 during theexamination procedure. Thus, the drainage opening 72 is preferablylocated to the side of the sheath tip to minimize interference with theoptical examination, as shown in FIGS. 9 and 12. In an alternateembodiment, drainage channel 56 may be eliminated.

Like the optical surgical device, the urethroscope sheath 62 ispreferably made of a semi-flexible material to provide for comfortableinsertion and manipulation with the patient. However, as discussedabove, the sheath material must be sufficiently rigid at the proximalend of the sheath to enable the physician to properly maneuver thedistal end of the sheath into the desired location. Accordingly, thediameter of the sheath 62 is larger toward the proximal end 54 forincreased strength and manipulability. The sheath is tapered toward itsdistal end 52 to minimize patient discomfort.

With regard to the described embodiments of the optical surgical deviceand the urethroscope device, the sheath 12 and 62 is disposable.Preferably, each sheath will be designated for single patient use only.After each examination or surgical procedure in which the sheath hasbeen inserted into the patient, the suction (or drainage)/irrigationport may be simply disconnected from the suction and irrigation sources,and the eyepiece and endoscope may be easily removed from (e.g., slippedout of) the respective endoscope channel. Consequently, the remainingempty sheath can be immediately disposed of without further cleaning orsterilization. Only the endoscope and the eyepiece may require cleaningand sterilization for future use. Thus, because of the disposablefeature of the outer sheath, the time and energy which would otherwisebe required to properly clean and sterilize the sheath are significantlyreduced.

In addition, because the sheath is pre-sterilized before each singleuse, the physician simply needs to remove the already-sterilized sheathfrom its packaging, attach it to the necessary suction/drainage andirrigation sources, insert the endoscope and attach the eyepiece. Thesurgical device is then ready for immediate use. Such constructionsignificantly decreases the complexity and margin for error duringexaminations and other operative procedures.

In the illustrated embodiments, the eyepiece coupled to the proximal endof the sheath and endoscope channel is arranged in-line with the sheathfor direct viewing capability. However, it will be recognized thatdepending upon the particular application or position of the patientduring the operative procedure, the eyepiece may be angled away from thebody of the sheath. Similarly, the suction (or drainage)/irrigation portmay be configured in a variety of other ways not shown in theillustrated embodiments to accommodate different configurations andpositions as necessitated by the examination procedure.

In addition, further embodiments may employ different numbers ofchannels as necessary for attachment to a variety of devices and/orsources necessary for different operative procedures. For example, achannel may be designated for the introduction of other instruments,such as a biopsy instrument for use in the patient's urinary bladder.Also, it will be recognized that other optical devices may be used toobserve the operative procedure.

FIG. 13 is a perspective view of an alternative embodiment of aurethroscope in accordance with the present invention. FIG. 14 is aperspective view of the urethroscope of FIG. 14, with an optical viewingdevice (such as a conventional 1 mm endoscope 112) protruding from botha distal end 109 and a proximal end 111 of a sheath 101.

The urethroscope 100 is dimensioned particularly for use within theurethra of a female patient. Compared to the urethra of a male, theurethra of a female is substantially shorter (about 3.8 cm versus about16 cm in a male). Because of the differences in dimension, difficulties(such as puncture) may be encountered when using a prior arturethroscope in the urethra of a female patient. Thus, the embodimentillustrated in FIGS. 13 and 14 is specifically sized for the femaleurethra, as will be described in detail below.

In FIG. 13, the sheath 101, which may be removable and disposable, hasmultiple channels 102, 104, 106. An inflation medium, such as a balloon68, is provided generally near the distal end 109 of the femaleurethroscope 100 (similar to the inflation medium 68 described in thetext referring to FIGS. 9-11). The balloon 68 is used to dilate a femalepatient's urethra when a substance, such as a liquid or gas, iscommunicated to the balloon 68. The balloon 68 is shown deflated in FIG.13 and inflated in FIG. 14.

In the preferred embodiment, an irrigation channel 102, similar to theirrigation channel 18 described above, is provided to communicate asubstance (such as a gas or liquid) to the tip of the distal end 109 ofthe female urethroscope 100. A connector 110 provides a means forcoupling the irrigation channel 102 to a source of fluid or gas. Anendoscope channel 104, similar to the endoscope channel 16 describedabove, is provided to allow the optical tip of the endoscope 112 to bepositioned generally at the tip of the distal end 109 of theurethroscope. The endoscope channel 104 may removably receive theendoscope 112. A balloon inflation/deflation channel (the "balloonchannel") 106, similar to the balloon inflating channel 71 shown inFIGS. 9-11 and described in the accompanying text, is provided tocommunicate the substance to the balloon 68. Optionally, the tip of thedistal end 109 may have a scraper or other tool.

In accordance with the present invention, the female urethroscope 100 issubstantially shorter than prior art urethroscopes. For example, thefemale urethroscope 100 depicted in FIG. 13 preferably has a length "L"of about 150 mm long from the tip of the distal end 109 to the point 113at which the irrigation channel 102, the endoscope channel 104, and theballoon inflation/deflation channel 106 diverge. This length "L" definesan "insertion portion" 107 of the female urethroscope 100. The insertionportion 107 may be curved (preferably along the distal half of theinsertion portion 107) and/or semi-flexible for ease of insertion,viewing access, and added comfort. Reducing the length "L" of theinsertion portion 107 of the female urethroscope 100 to less thanapproximately 180 mm allows the user more easily to insert the femaleurethroscope 100 into, and to manipulate the female urethroscope 100within, the urethra of a female patient. Furthermore, the diameter "d"of the female urethroscope 100 is preferably less than about 7 mm, andespecially less than about 4 mm. As a result of the dimensions "L" and"d", the female urethroscope 100 may be inserted more comfortably intothe urethra of a female patient.

An eyeport 64 at the proximal end 111 of the female urethroscope 100 isessentially identical to the eyeport 64 shown in FIG. 9 and discussed inthe accompanying text. That is, in the preferred embodiment, the eyeport64 is co-axial with the sheath 101. Accordingly, neither a personlooking nor equipment receiving images through the female urethroscope100 need be repositioned if the sheath 101 is rotated about a centrallongitudinal axis of the sheath 101. That is, because the centrallongitudinal axis of the endoscope channel 104 is preferably coincidentwith the central longitudinal axis of the sheath 101 (i.e., co-axial),and because the endoscope channel 104 is generally symmetrical about thecentral longitudinal axis, rotation of the sheath 101 does not relocatethe eyeport 64. Also, the balloon 68 is essentially similar to theballoon 68 shown in FIGS. 9 and 10 and discussed in the accompanyingtext. A connector 108 provides a means for securely coupling a source ofeither gas or liquid to the balloon channel 106. As discussed withregard to each of the other embodiments of the present invention, thesheath 101 is preferably disposable.

FIGS. 15 and 16 illustrate an alternative embodiment 200 of the femaleurethroscope of the present invention. FIG. 15A shows a side view ofthis embodiment of the female urethroscope, and FIG. 15B shows an endview (from the distal end 209) of the female urethroscope, both FIGURESillustrating an inflation medium 68 in a deflated state. FIGS. 16A and16B, respectively, show a side view and end view (from the distal end209) of the female urethroscope of FIGS. 15A and 15B, with the inflationmedium 68 in an inflated state.

Like the embodiment illustrated in FIGS. 13 and 14, the femaleurethroscope 200 is dimensioned for use in the urethra of a femalepatient. Thus, the length "L", measured from the distal end 209 of theurethroscope 200 to a divergence point 213 of an irrigation channel 202and on inflation/deflation channel 206, is approximately 150 mm or less.This length "L" defines an "insertion portion" 207 of the femaleurethroscope 200. Further, a diameter "d" of the female urethroscope 200is preferably less than about 7 mm, and especially less than about 4 mm.With such dimensions "L" and "d", the female urethroscope 200 can bemore comfortably inserted into the female urethra than prior art devicescan.

The female urethroscope 200 includes a sheath 201, which may beremovable and disposable, the irrigation channel 202, theinflation/deflation channel 206, and an endoscope channel 204, whichchannels diverge at the divergence point 213. These channels are similarto their respective counterparts 102, 106, 104 described above for thefemale urethroscope 100 of FIGS. 13 and 14.

The female urethroscope 200 has an inflation medium 68, which operatesand functions like that described above for the female urethroscope 100of FIGS. 13 and 14. FIG. 15B is a view from the distal end 209 of thefemale urethroscope 200, showing the tip 220 of the urethroscope 200with the inflation medium 68 in a deflated state. FIG. 16B is the sameview as that in FIG. 15B, showing the tip 220 with the inflation medium68 in an inflated state.

In an alternative embodiment of the present invention, the femaleurethroscopes 100 and 200 may include more, fewer, or differentchannels. For example, an alternative embodiment of the femaleurethroscope in accordance with the present invention may includeseparate irrigation and drainage channels to allow simultaneous ingressand egress of fluids and particulates.

Other features of the female urethroscopes 100 and 200 are essentiallyas shown and described with respect to FIGS. 9-12. For example, asdescribed with respect to the embodiment illustrated in FIG. 9, and asnoted above, the sheath 101 (or 201) of the female urethroscope 100 (or200) is preferably slightly curved. The slight curvature providessufficient flexibility, as well as physical and visual access to thevarious areas of the operative site. Accordingly, the curvature affordsa greater viewing angle as the sheath 101 (or 201) is rotated, andgreater control over the position of the distal end 109 (or 209) of thefemale urethroscope 100 (or 200) within a urethra of a female patient.

FIGS. 17A, 17B, 17C, 17D show yet another embodiment of the presentinvention. FIG. 17A is a side view of a two-lumen female urethroscope300. FIG. 17B is an enlarged side view of the distal tip of thetwo-lumen female urethroscope 300 of FIG. 17A. FIG. 17C is across-sectional side view of the two-lumen female urethroscope 300 ofFIG. 17A. FIG. 17C is an enlarged cross-section side view of the distaltip of the two-lumen female urethroscope 300 of FIG. 17A.

FIG. 17D shows an aspiration lumen 302. Situated within the aspirationlumen 302 is an irrigation lumen 304. The irrigation lumen 304 is sizedto directly accept an endoscope 306 (that is, there is no separateendoscope lumen). In use during an examination of a patient's bladder,irrigation fluid flows down the female urethroscope 300 through a firstport 308, past the distal tip of the endoscope 306, and out into thepatient's bladder. Fluid may be taken in through a number of aspirationports 310 near the distal tip of the endoscope 306 for removal via asecond port 312. Use of only two lumens substantially simplifies themanufacture of the urethroscope 300. This embodiment may have aninflation medium similar to that shown in FIG. 15A, a straight or curveddistal end, and an optional scraping tip.

A number of embodiments of the present invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, it is to be understood that the invention is not to belimited by the specific illustrated embodiment, but only by the scope ofthe appended claims.

I claim:
 1. A method of using a female urethroscope, the femaleurethroscope having a disposable sheath, the disposable sheath having(1) an open proximal end, an open distal end, and an insertion portion,the sheath being dimensioned for comfortable insertion into a urethra ofa female patient, the urethra having an interior wall, an overalldiameter of the distal end being less than approximately 7 mm and thelength of the insertion portion of the sheath being less thanapproximately 150 mm, an inflation medium being generally disposed nearthe distal end of the sheath and (2) at least two channels integrallyformed within the sheath and extending between the open proximal end andthe open distal end, the channels including an endoscope channel forremovably receiving an optical viewing device and an inflation channelfor communicating a gas or liquid to the inflation medium to cause theinflation medium to apply pressure to, and release such pressure from,the interior wall of the urethra of the female patient, including thesteps of:(a) inserting the optical viewing device into the endoscopechannel; (b) inserting the insertion portion of the sheath into theurethra of the female patient; (c) viewing the position of the distalend of the sheath with respect to the urethra; (d) communicating asubstance through the inflation channel to the inflation medium to causethe inflation medium to apply pressure to the interior wall of theurethra; (e) relieving the pressure to the interior wall of the urethraby allowing the substance to flow out of the inflation medium throughthe inflation channel; and (f) removing the insertion portion of thesheath from the urethra.
 2. The method of claim 1 wherein the step ofcommunicating a substance through the inflation channel to the inflationmedium causes the inflation medium to dilate the entire length of theurethra.
 3. The method of claim 1 wherein the at least two channelsfurther include an aspiration channel and wherein the method furtherincludes removing matter from a urinary tract of the female patientthrough the aspiration channel.
 4. The method of claim 1 furthercomprising providing an irrigating fluid through the endoscope channel.